An observational study in Scoliosis; Idiopathic, Infantile, Scoliosis; Juvenile and Scoliosis Neuromuscular, sponsored by Oslo University Hospital. Status unknown at 1 site in Norway. Open to participants aged 1 Year to 20 Years. Per ClinicalTrials.gov, last updated 2021-09-20.
Sponsored by Oslo University Hospital · Observational
Observation study about physical activity, motor competence, pulmonary function, and health related quality of life in children, surgically treated for early onset scoliosis
Early Onset Scoliosis (EOS) defines patients who develop deformities of the spine and/or thorax in the embryologic development or in the early childhood. The exact prevalence of EOS in Norway is unknown, but it is assumed to be approximately 200-300 new EOS patients every year. EOS is a severe condition, whereby some of the most common and also most severe consequences of the deformity are severe pulmonary problems. The patients may require extensive orthopedic treatment from early childhood and until maturity to avoid serious consequences with severe pulmonary problems and shortening of life.
EOS' secondary problems, including severe consequences on the pulmonary function might contribute to enhanced inactivity. Inactivity contributes to further negative impact on development of the musculoskeletal system, motor competence and pulmonary function. Considering the severity of EOS and children's reduced life expectancy, it is extremely important that EOS children achieve the favorable impact of physical activity during their growth. Insufficient level of activity might worsen the prognosis, thus counteracting the treatment's ambitions. The investigator's aim is to extend the knowledge about level of activity, motor competence, pulmonary function, and health related quality of life in Norwegian children, surgically treated for EOS.
660 studies on the registry are indexed under Scoliosis; 186 are open to participants now.
This study's planned enrollment of 50 is below the median of 84 across 256 observational studies indexed under Scoliosis.
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Children treated at the Norwegian National Unit for Surgical Treatment of Non-malignant Pathologies in Pediatric Spine, Oslo University Hospital
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Exclusion Criteria:
Physical Activity, assessed by use of accelerometer
Physical Activity will be measured objective by use of an accelerometer (used over 7 days), recorded as Activity Counts/ minutes
Time frame: Change in activity counts from baseline to activity counts at 6 months and 12 months.
Airway resistance, assessed by use of plethysmography
Children \>8 years will also be assessed by use of plethysmography. Airway resistance will be measured, recorded as the ratio of driving pressure divided by flow through the airways
Time frame: Change in measures from baseline and to 12 months
Pulmonary residual volume and total lung capacity, assessed by use of plethysmography
Children \>8 years will also be assessed by use of plethysmography. Residual volume (liters) and total lung capacity (liters) will be measured.
Time frame: Change in measures from baseline and to 12 months
Pulmonary function, assessed by use of diffusion capacity test
Children \>8 years will be assessed by use of diffusion capacity test. Diffusing capacity or transfer factor of the lung for carbon monoxide (CO) (DLCO) will be measured.
Time frame: Change in measures from baseline and to 12 months
Pulmonary function, assessed by use of spirometry
All participants will go through spirometry. Vital capacity (VC), Forced vital capacity (FVC), Forced expiratory volume (FEV) at timed intervals of 0.5, 1.0 (FEV1), 2.0, and 3.0 seconds and maximal voluntary ventilation (MVV) will be measured (liters)
Time frame: Change in measures from baseline and to 12 months
Forced expiratory flow, assessed by use of spirometry
All participants will go through spirometry. Forced expiratory flow 25-75% (FEF 25-75) will be measured (liters/second)
Time frame: Change in measures from baseline and to 12 months
Motor competence, assessed by use of Movement Assessment Battery of Children- 2. edition
Motor competence will be assessed by use of Movement Assessment Battery of Children- 2. edition
Time frame: Baseline and after 12 months
Health related quality of life in children
Health related quality of life will be assessed by use of the Early Onset Scoliosis 24-item Questionnaire (EOSQ-24). Total score, ranged 0 (worst) to 100 (best), including 11 subdomain scores, ranged 0 (worst) to 100 (best) will be calculated.
Time frame: Change in parents answers of health related quality of life of their child from baseline, to 6 months and to 12 months.
Health related quality of life in adolescents
Among participants \> 16 years, health related quality of life will be assessed by use of the Scoliosis Research Society 22- item (SRS-22) questionnaire. Total score and 5 subdomain scores, all ranged 5 (best) to 1 (worst), will be calculated.
Time frame: Change in subjective answers of health related quality of life from baseline, to 6 mounts and to 12 mounts.
Shoulder function
A physiotherapist will assess the active shoulder range of motion, categorized as normal, active range of motion \>50% of perceived motion, or active range of motion \<50% of perceived motion. shoulder flexion, extension, abduction, and rotation will be measured.
Time frame: Baseline and after 12 months
Physical Activity, assessed by use of questionnaire
Physical Activity will be subjective measured by use of a questionnaire regarding participants' everyday activity. Participants range their activity in several sports activities from never (1) to several days a week (4).The questionnaire is previous used in a national survey study regarding physical activity among children and adolescents in Norway.
Time frame: Change in subjective answers of everyday activity from baseline, to 6 mounts and to 12 mounts.
Plan to share: No
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The record gives a start of Nov 2016, a primary completion of Jan 2022 and a completion of Dec 2022. It does not say whether these dates are actual or estimated.
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This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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